A Prospective, Multi-centre, Active Post-Marketing Surveillance Study of Liposomal Amphotericin B (AmphonexÂ® - Manufactured by Bharat serums and Vaccines ltd) in Patients with Invasive Fungal infection who are refractory to or intolerant of conventional Amphotericin B therapy in Real World Clinical Practice (AMBeR) - AMBeR

Bharat Serums and Vaccines Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年5月29日

研究概览

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•Subjects of either gender >= 18 years of age.
•Subjects who are prescribed Liposomal Amphotericin B or have started Liposomal Amphotericin B (AmphonexÂ®) treatment as per Investigatorâ??s discretion for current illness.
•Subjects/LAR willing and able to give written informed consent according to applicable regulatory requirements.

•History of anaphylactic or other severe systemic reaction to Lipid-based amphotericin b or any of its excipients.
•Subjects suffering from any medical condition that in the investigatorâ??s opinion could compromise the subjectâ??s ability to participate in the clinical study.
•Subject participating prospectively in another clinical study within the last four weeks before the enrolment to the study.
•In the last six weeks Subject have taken any amphotericin B preparation other than AmphonexÂ®.
•Subjects on therapy with Nephrotoxic drugs including but not limited to aminoglycosides, cyclosporine, polymyxin B and tacrolimus.
•Pregnant or nursing females.

发起方

Bharat Serums and Vaccines Ltd